bio Reports First Quarter 2024 Financial Results and Provides Corporate Update Initiated Phase 3 ENLIGHTEN-Fibrosis trial in non-cirrhotic (F2-F3) metabolic dysfunction-associated steatohepatitis (MASH) patients Expect t

89bio Reports First Quarter 2024 Financial Results and Provides Corporate Update

Initiated Phase 3 ENLIGHTEN-Fibrosis trial in non-cirrhotic

(F2-F3) metabolic dysfunction-associated steatohepatitis (MASH) patients

to initiate ENLIGHTEN-Cirrhosis trial this quarter in MASH patients with compensated cirrhosis (F4)

Medicines (PRIME) status from the European Medicines Agency (EMA) for pegozafermin in the treatment of MASH with fibrosis and compensated cirrhosis

Data from the 48-Week Extension Phase of the ENLIVEN Phase 2b Trial to be presented at the

European Association for the Study of the Liver Congress (EASL)

SAN FRANCISCO, May 9, 2024 (GLOBE NEWSWIRE) 89bio, Inc. (Nasdaq:

ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today reported its financial results for the first quarter ended

We are excited to have initiated ENLIGHTEN-Fibrosis, the first of two pivotal Phase 3 trials addressing MASH, and we are on

track to begin the ENLIGHTEN-Cirrhosis trial for compensated cirrhotic MASH patients in the second quarter, stated Rohan Palekar, CEO of 89bio. Because of its demonstrated anti-fibrotic and metabolic benefits, we believe that

pegozafermin has the potential to be the leading therapy in treating advanced MASH patients with fibrosis. We are focused on the execution of our Phase 3 trials for MASH and our synergistic Phase 3 trial in severe hypertriglyceridemia (SHTG), which

we anticipate topline data from in 2025. These key clinical developments, coupled with our agreement for commercial supply, are designed to strategically enhance our readiness for potential commercialization.

Recent Highlights and Anticipated Milestones

Metabolic dysfunction-associated steatohepatitis (MASH)

Presenting Author: Rohit

Loomba, M.D., MHSc, Chief of the Division of Gastroenterology and Hepatology at University of California San Diego School of Medicine, and lead investigator of the ENLIGHTEN program

Presenting Author: Arun J. Sanyal, MBBS, M.D., Director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health,

Virginia Commonwealth University and lead investigator of the ENLIVEN trial

Severe Hypertriglyceridemia (SHTG)

First Quarter 2024 Financial Results

Position. As of March 31, 2024, 89bio had cash, cash equivalents and marketable securities of approximately $562.3 million.

Research and Development (R&D) Expenses. R&D expenses were $47.4 million for the three

months ended March 31, 2024, compared to $22.3 million for the three months ended March 31, 2023. The increase in R&D expenses was primarily driven by increases in contract manufacturing, clinical development and personnel-related

expenses, including stock-based compensation driven by higher headcount.

General and Administrative (G&A) Expenses. G&A expenses were

$9.8 million for the three months ended March 31, 2024, compared to $6.2 million for the three months ended March 31, 2023. The increase in G&A expenses was primarily due to an increase in professional fees and

personnel-related expenses including stock-based compensation driven by higher headcount.

Net Loss. 89bio reported a net loss of

$51.7 million for the three months ended March 31, 2024, compared to a net loss of $28.8 million for the three months ended March 31, 2023. The increase in net loss was primarily attributable to increased R&D expenses to

advance the company s programs, increased G&A expenses associated with higher headcount, and expenses to support the company s expanded operations.

89bio is a clinical-stage biopharmaceutical

company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The company is

focused on rapidly advancing its lead candidate, pegozafermin, through clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically

engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an

extended half-life. The company is headquartered in San Francisco. For more information, visit www.89bio.com or follow the company on LinkedIn.

Forward-looking Statements

Certain statements in this

press release may constitute forward-looking statements within the meaning of the federal securities laws, including, but not limited to, statements regarding the therapeutic potential and utility, efficacy and clinical benefits of

pegozafermin, the safety and tolerability profile of pegozafermin, trial designs, clinical development plans and timing for pegozafermin, including the initiation of the Phase 3 ENLIGHTEN-Cirrhosis trial in MASH and the topline results from the

ENTRUST Phase 3 trial in SHTG, and enrollment in clinical trials, including enrollment of the Phase 3 ENLIGHTEN-Fibrosis trial in MASH and ENTRUST Phase 3 trial in SHTG. Words such as may, might, will,

objective, intend, should, could, can, would, expect, believe, design, estimate, predict, potential,

anticipate, goal, opportunity, develop, plan or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking

statements. While 89bio believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These

forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in 89bio s filings with the Securities and Exchange Commission

many of which are beyond 89bio s control and subject to change. Actual results could be materially different. Risks and uncertainties include: expectations regarding the initiation of the

ENLIGHTEN-Cirrhosis Phase 3 trial in MASH; expectations regarding the timing and outcome of the ENLIGHTEN-Fibrosis Phase 3 trial in MASH and ENTRUST Phase 3 trial in SHTG; 89bio s ability to execute on its strategy; positive results from a

clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; 89bio s substantial dependence on the success of it lead product candidate; competition from competing products; the impact of general

economic, health, industrial or political conditions in the United States or internationally; the sufficiency of 89bio s capital resources and its ability to raise additional capital; and other risks and uncertainties identified in 89bio s

Annual Report on Form 10-K for the year ended December 31, 2023 and other subsequent disclosure documents filed with the SEC. 89bio claims the protection of the Safe Harbor contained in the Private

Securities Litigation Reform Act of 1995 for forward-looking statements. 89bio expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

Condensed Consolidated Statement of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

Condensed Consolidated Balance Sheet Data

LifeSci Advisors, LLC